NCT05211713

Brief Summary

The aim of the project is firstly, to develop an app-based mental health intervention for adolescents. Secondly, to evaluate the effect of this app. The overarching goal is to offer a low-threshold intervention, called Opp, that is easily accessible and free to use for all adolescents in Norway.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
399

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2023

Completed
Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

1.3 years

First QC Date

December 15, 2021

Last Update Submit

May 6, 2026

Conditions

Keywords

Mental health promotionCopingAdolescentsMobile application

Outcome Measures

Primary Outcomes (2)

  • Change in WHO-5 (WHO-Five Well-being Index)

    WHO-5 (WHO, 1998): A five item self-report questionnaire assessing well-being on a six point scale.

    Change from baseline to six weeks after intervention.

  • Change in SDQ (Strengths and Difficulties Questionnaire)

    SDQ (Goodman, 1997): A 25 item self-report assessing mental health and psychosocial functioning in 11-17 years old adolescents on a three point scale.

    Change from baseline to six weeks after intervention.

Secondary Outcomes (4)

  • General Self-efficacy scale (GSE)

    Change from baseline to six weeks after intervention.

  • Help-seeking behavior

    Change from baseline to six weeks after intervention.

  • Self-liking and Competence Scale

    Change from baseline to six weeks after intervention.

  • Sleeping quality

    Change from baseline to six weeks after intervention.

Study Arms (2)

Intervention group receiving Opp

EXPERIMENTAL

The effectiveness study will be conducted as a randomized controlled trial with an intervention group and a waiting-list control group. Data will be collected at baseline (T1, pre intervention) and after about six weeks of intervention (T2, post intervention).

Device: Opp

Control group

NO INTERVENTION

The waiting list control group will receive the intervention after study completion.

Interventions

OppDEVICE

Opp is a universal mental health promoting mobile application for adolescents aged 13-25 years.

Intervention group receiving Opp

Eligibility Criteria

Age13 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescents under 16 years whose guardians have given consent

You may not qualify if:

  • severe developmental or cognitive challenges

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UiT The Arctic University of Norway

Tromsø, Norway

Location

Related Publications (2)

  • Hogsdal H, Kaiser S, Mabille G, Martinussen M, Jakobsen R, Kyrrestad H. The effect of a universal mobile application on adolescents' mental health and well-being. Internet Interv. 2025 Feb 18;40:100814. doi: 10.1016/j.invent.2025.100814. eCollection 2025 Jun.

  • Kaiser S, Rye M, Jakobsen R, Martinussen M, Hogsdal H, Kyrrestad H. A Universal Mental Health-Promoting Mobile App for Adolescents: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2023 Jan 11;12:e42119. doi: 10.2196/42119.

Related Links

Study Officials

  • Henriette Kyrrestad, PhD

    UiT The Arctic University of Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Intervention and control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2021

First Posted

January 27, 2022

Study Start

August 1, 2022

Primary Completion

November 15, 2023

Study Completion

November 15, 2023

Last Updated

May 11, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations